索拉非尼联合干扰素治疗晚期肾癌的临床效果分析

Efficacies of sorafenib plus interferon in advanced renal cell carcinoma： a report of 57 cases

目的探讨索拉非尼治疗晚期肾癌的效果和不良反应。方法收集总结大连医科大学附属第一医院2007年4月至2011年10月泌尿外科门诊收治的有完整临床病理资料的晚期肾癌患者共57例，其中24例为索拉非尼组，33例为索拉非尼＋干扰素组，研究的主要终点为客观反应率、无进展生存期，次要终点为总生存期、不良反应发生率。结果索拉非尼组平均服药15（7—56）个月。其中部分缓解1例、疾病稳定8例、疾病进展1例，死亡14例，客观反应率4．2％（1／24），疾病控制率37．5％（9／24）。索拉非尼＋干扰素组平均服药15（4—30）个月，部分缓解2例、疾病稳定21例、疾病进展l例，死亡9例，客观反应率6．1％（2／33），疾病控制率69．7％（23／33）。两组主要不良反应发生率和严重程度差异均无统计学意义（均P〉0．05）。结论索拉非尼治疗晚期肾癌安全有效，不良反应多数患者可耐受。加用干扰素治疗可显著提高治疗效果，而不良反应率并无增加。

Objective To explore the efficacies and adverse events of sorafenib in the treatment of advanced metastatic renal cell carcinoma. Methods A total of 57 patients with advanced kidney cancer were recruited from our hospital from April 2007 to October 2011. They were divided into sorafenib group （ A, n = 24） and sorafenib ＋ IFN group （ B, n = 33 ）. The primary endpoints included objective response rate and progression-free survival （ PFS）. And the secondary endpoints were overall survival （ OS ） and incidence of adverse events. Results The mean medication time of group A was 15 （7 -56） months. The outcomes were partial response （ PR, n = 1 ）, stable disease （ SD, n = 8）, progressive disease （ PD, n = 1 ） and death （n = 14）. The rates of objective response and disease control were 4. 2% （1/24） and 37. 5% （9/24） respectively. For group B, the mean medication time was 15 （4 -30） months. The outcomes were PR （n =2）, and include 2 patients of PR, 21 examples of SD, 1 patient of PD and death. The rates of objective response and disease control were 6. 1% （2/33） and 69. 7% （23/33） respectively. Two groups had no significant difference in incidence or severity of adverse events （ both P 〉 0. 05）. Conclusions As a safe and effective agent for advanced kidney cancer, sorafenib is well-tolerated in patients. The combined use of interferon may improve the therapeutic efficacies without an occurrence of adverse events.